Novel Baroreflex Activation Therapy in Resistant Hypertension Results of a European Multi-Center Feasibility Study
Novel Baroreflex Activation Therapy in Resistant Hypertension Results of a European Multi-Center Feasibility Study
复制标题
DOI:
10.1016/j.jacc.2010.03.089
复制
发表时间:
2010-10-05
影响因子:
24
通讯作者:
de Leeuw, Peter W.
中科院分区:
文献类型:
--
作者:
Scheffers, Ingrid J. M.;Kroon, Abraham A.;de Leeuw, Peter W.
Objectives This study assessed the safety and efficacy of a novel implantable device therapy in resistant hypertension patients.Background Despite the availability of potent antihypertensive drugs, a substantial proportion of patients remain hypertensive. A new implantable device (Rheos system, CVRx, Inc., Minneapolis, Minnesota) that activates the carotid baroreflex may help these patients.Methods Forty-five subjects with systolic blood pressure >= 160 mm Hg or diastolic >= 90 mm Hg despite at least 3 antihypertensive drugs were enrolled in a prospective, nonrandomized feasibility study to assess whether Rheos therapy could safely lower blood pressure. Subjects were followed up for as long as 2 years. An external programmer was used to optimize and individualize efficacy.Results Baseline mean blood pressure was 179/105 mm Hg and heart rate was 80 beats/min, with a median of 5 antihypertensive drugs. After 3 months of device therapy, mean blood pressure was reduced by 21/12 mm Hg. This result was sustained in 17 subjects who completed 2 years of follow-up, with a mean reduction of 33/22 mm Hg. The device exhibited a favorable safety profile.Conclusions The Rheos device sustainably reduces blood pressure in resistant hypertensive subjects with multiple comorbidities receiving numerous medications. This unique therapy offers a safe individualized treatment option for these high-risk subjects. This novel approach holds promise for patients with resistant hypertension and is currently under evaluation in a prospective, placebo-controlled clinical trial. (J Am Coll Cardiol 2010;56:1254-8) (C) 2010 by the American College of Cardiology Foundation